Specialty pharmaceutical company CMP Pharma, Inc. announced that its Potassium Phosphates Injection, the first ever FDA Approved Potassium Phosphates Injection, was approved on September 19, 2019.
“This will provide Health Care Providers, for the first time, an FDA approved potassium phosphates injection. The availability of this product will help alleviate supply concerns from previous market shortages of this critical phosphate repletion treatment” said CMP Pharma’s
Potassium Phosphates Injection is indicated as a source of phosphorus in intravenous fluids to correct hypophosphatemia in adults and pediatric patients 12 years of age and older when oral or enteral replacement is not possible, insufficient or contraindicated. Additionally, it is indicated as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions.
CMP’s Potassium Phosphates Injection provides a stable, reliable, and easy-to-dose therapeutic option to healthcare professionals. Many practitioners and pharmacists are unaware that all current potassium phosphates formulations on the market today are products that have not been approved by the FDA. These unapproved products have not undergone FDA’s review process for quality, safety and efficacy and therefore can expose patients, as well as physicians, to unknown risks.
A major concern with the unapproved potassium phosphates formulations is aluminum toxicity. The FDA has established allowable limits for aluminum in injectable products, and current unapproved potassium phosphates injectable products on the market significantly exceed these limits.
CMP’s Potassium Phosphates Injection will help address the critical demand for potassium phosphates while providing physicians and their patients with a product that meets FDA standards for quality, safety and efficacy
Leave a Reply